Good job FDA.
FDA also needs to
tear apart
non-inferiority
trials used to toss
in very expensive
me-too drugs into
the market. This is
especially true of
the very expensive
biologicals and
touted alternatives
to useful drugs like
anticoagulants,
Proton pump
inhibitors,
anti-hypertensives..

Michael S

02/11/14

I believe there is a study originating in England about two years ago that compared all of the RX COX-II's that are
available and OTC NSAIDS and they found that naproxen is significantly more safe than any of the other brands.
Based on that I started taking one 500mg tab BID for my arthritis pain and was cleared by two of my doctors, a
cardiologist and Fam Practice. There really isn't very many pain medications for CV patients to take to relieve
minor pain, the next step would be hydrocordone which can be habit forming. I definitely would stay away from
ibuprofen..

EWB, RN MSN

02/11/14

So , about all that's clear here is that the panel has effectively declined to decide due to a lack of consensus on
most specifics?.

stephen bookbinder

02/11/14

The FDA is being
obtuse here. There
are two major
reasons for MI
increases in using
Nsaids. They are
hypertension and
thrombosis. The
problem with the
FDA's simplistic
black box warning is
it doesn't
differentiate
between the two.
Conventional Nsaids
prolong bleeding
time by causing
platelet inhibition.
Indeed a study in
1989 using
Flurbuprofen for
post coronary artery
bypass pain showed a
decrease in post
graft thrombosis. A
similar study using
Bextra IV showed an
increase in post
graft thrombosis.
Bextra Vioxx and
Celebrex as
selective cox2
inhibitors have a
theoretical tendency
towards causing
vasoconstriction and
platelet
aggregation.
All Nsaids can
effect renal blood
flow which can
result in
hypertension. So
theoretically if
blood pressure is
controlled older
nsaids like Naproxen
might actually show
a reduction in
cardiac infarcts
where as Selective
Cox2 drugs might
still show an
increase due to its
pro thrombotic
effect. Celebrex at
a 200mg a day dose
caused less benefit
and less
hypertension than
Vioxx and Bextra. So
its weakness was its
benefit and could be
why its cardiac
profile is more
favorable than the
discontinued Cox2
drugs.
Depriving an
osteoarthritic the
benefit of an
antiinflammatory for
an overblown fear of
cardiac disease is
buffoonery.As a
rheumatologist I
would consider it
malpractice. Avoid
Celebrex in patients
with known
thrombotic
disorders. Control
hypertension and
protect against GI
ulcerations using
conventional Nsaids
. Watch renal
function.
While we are at
it why did the FDA
give Celebrex such a
long patent
extension and refuse
to differentiate its
cardiac effects from
older Nsaids? Why
was Enbrel's patent
extended over 10
years? There is alot
of money floating
around on capital
hill and I fear
collusion at the
highest levels of
the FDA..

C.Carroll, PA-C

02/11/14

The FDA is giving me a headache. Do they even
know what they are doing anymore?.

unknown1

02/11/14

@stephen bookbinder
"I fear collusion at
the highest levels
of the FDA".
So do I....

ELW

02/12/14

On a personal basis I do not take any Nsaids, in spite of having
daily back and neck pain from past injuries. I have yet to find
one that does not completely disrupted my digestive system and end
up causing me stomach pains. I figure anything that can do that to
you has got to be bad. On a professional basis, I stopped believing
the claims of Pharma and the FDA decades ago when they reversed
their decision on the safety of Hormone Replacement Therapy. I may
change that belief when the FDA stops taking money from the Pharma
industry..

Ann Wooledge

02/17/14

I personally have severe cervical spine pain and not wanting to use NSAID'S or prescription drugs have been successfully using generic gabapentin bid with great success..

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